BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Neu Platform

    K Number: K250153 · Decision Apr 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    94

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Neu Platform
    K Number
    K250153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuhealth Digital , Ltd.
    Date Received
    January 21, 2025
    Decision Date
    April 25, 2025
    Product Code
    GYD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GYD Transducer, Tremor

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GYD), ordered by most recent decision date.

    Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroRPM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Parky App

    FDA 510(k)
    FDA Class 2 ·Neurology

    Rune Labs Tremor Transducer System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Personal Kinetigraph (PKG) System Gen 2 Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    Personal Kinetigraph (PKG) System

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all